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Evaluation of Dental Bleaching In-office (Bleaching)

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ClinicalTrials.gov Identifier: NCT03192852
Recruitment Status : Unknown
Verified June 2017 by Anna Carolina Ratto Tempestini Horliana, University of Nove de Julho.
Recruitment status was:  Not yet recruiting
First Posted : June 20, 2017
Last Update Posted : June 23, 2017
Sponsor:
Information provided by (Responsible Party):
Anna Carolina Ratto Tempestini Horliana, University of Nove de Julho

Brief Summary:
We aim to evaluate colorimetric changes after supervised whitening treatment, using Violet LED light associated or not with carbamide peroxide 35% gel. 80 will be divided into: Group 1 - Violet LED light, Group 2 Violet LED light + carbamide peroxide 35% gel, Group 3 -hydrogen peroxide 35% and Group 4 will be submitted to the gingivoplasty surgery procedure, for aesthetic desire, after whitening treatment with Violet LED light without gel. The colorimetric changes will be measured before, right after each whitening session in the end of the period of 3 months, through the Vitapan Classical (Vita) color scale, and by digital spectrophotometer. The sensibility degree will be measured by the Visual Analogue Scale (VAS) . The gum tissues Group 4, will be analyzed by histomorphometrically. Quality of life will be evaluated.

Condition or disease Intervention/treatment Phase
Esthetics, Dental Other: dental bleaching Procedure: Gingivoplasty Not Applicable

Detailed Description:
This randomized, blind controlled trial has the objective of evaluate colorimetric changes after supervised whitening treatment, in-office, using Violet LED light of 405 nm associated or not to the use of carbamide peroxide 35% gel. Eighty patients, of which 20 with aesthetics desires to be submitted to gingivoplasty surgery, will be divided into four groups. Group 1 will receive whitening only with Violet LED light (405 nm). Group 2 will receive a whitening treatment combination of Violet LED light with carbamide peroxide 35% gel. Patients of Group 3 will receive a whitening treatment with hydrogen peroxide 35% and Group 4 will be submitted to the gingivoplasty surgery procedure, for aesthetic desire, after whitening treatment with Violet LED light (405 nm) without gel. The colorimetric changes will be measured before, right after each whitening session in the end of the period of 3 months, through the Vitapan Classical (Vita) color scale, and by digital spectrophotometer (SpectroShade™ Micro MHT Optic Research). The sensibility degree will be measured by the Visual Analogue Scale (VAS) in each session and in all groups. The gum tissues removed during the gingivoplasty in Group 4, will be histomorphometric analyzed to measure possible inflammatory gum changes by the Violet LED light (405 nm) irradiation. The degree of satisfaction of the patient and the life quality after aesthetic result achieved will be evaluated. The results will be presented by means and standard deviation. After checking the normality of the data, a one-way ANOVA will be performed. In case the data do not follow a normal distribution, it will be utilized the Kruskal-Wallis test and a value of p <0.05.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: We will use a gel with no effect only in the fourth session of group 3 to match the number of sessions in relation to the other groups
Primary Purpose: Treatment
Official Title: Evaluation of Bleaching In-office With Violet LEd Light (405 nm): Randomized, Controlled Double Blind and Clinical Trial
Estimated Study Start Date : December 12, 2017
Estimated Primary Completion Date : January 17, 2019
Estimated Study Completion Date : April 17, 2019

Arm Intervention/treatment
Experimental: Violet LED (405 nm)+ gel placebo
20 patients will be submitted to dental bleaching involving the teeth 15-25 and 45 - 35 with Violet LED 405 nm (Bright Max Whitening, MMO, São Carlos, SP, Brazil) with gingival barrier + gel placebo
Other: dental bleaching
dental bleaching can be achieved with light, light+ peroxide carbamide gel, or only with peroxide carbamide gel

Experimental: Violet LED + CP 35%
20 patients will be submitted to dental bleaching involving the teeth 15-25 and 45 - 35 with carbamide peroxide 35% ( Whiteform - Fórmula & Ação, São Paulo, Brazil) actived with Violet LED 405 nm (Bright Max Whitening, MMO, São Carlos, SP, Brazil) with gingival barrier
Other: dental bleaching
dental bleaching can be achieved with light, light+ peroxide carbamide gel, or only with peroxide carbamide gel

Experimental: HP 35%
20 patients will be submitted to dental bleaching involving the teeth 15-25 and 45 - 35 with hydrogen peroxide 35% (Whiteness HP, FGM, Joinvile, SC, Brasil) and gingival barrier
Other: dental bleaching
dental bleaching can be achieved with light, light+ peroxide carbamide gel, or only with peroxide carbamide gel

Experimental: HP 35% + Violet LED + Gingivoplasty
20 patients will be submitted to dental bleaching involving the teeth 15-25 and 45 - 35 with Violet LED 405 nm (Bright Max Whitening, MMO, São Carlos, SP, Brazil) with gingival barrier split-mouth at first session. After 48 hours will be do Gingivoplasty.
Other: dental bleaching
dental bleaching can be achieved with light, light+ peroxide carbamide gel, or only with peroxide carbamide gel

Procedure: Gingivoplasty
gengivoplasty will be realized to in illuminated tissue an no illuminated tissue to morphometrically evaluate the tissue




Primary Outcome Measures :
  1. Color Evaluation [ Time Frame: baseline ]
    Color evaluation will be done before and after each bleaching session through the Vita Classical scale (VITA Zanhnfabrik, BadSӓckingrn, Germany) and SpectroShade ™ Micro MHT Optic Research by a previously trained and blind evaluator in the 4 groups

  2. Color Evaluation [ Time Frame: 3 months ]
    Color evaluation will be done 3 months after bleaching through the Vita Classical scale (VITA Zanhnfabrik, BadSӓckingrn, Germany) and SpectroShade ™ Micro MHT Optic Research by a previously trained and blind evaluator in the 4 groups


Secondary Outcome Measures :
  1. pain [ Time Frame: baseline ]
    The pain will be evaluated through the Visual Analogue Scale (VAS) at each session before and after bleaching in the 4 groups.

  2. pain [ Time Frame: 3 months ]
    The pain will be assessed through the Visual Analogue Scale (VAS) 3 months after the end of tooth whitening in the 4 groups.

  3. Quality of life [ Time Frame: baseline ]
    Quality of life will be assessed through the Psychosocial Impact of Dental Aesthetics Questionnaire validated for Brazil at the Federal University of São Paulo (UNIFESP)

  4. Quality of life [ Time Frame: 3 months ]
    Quality of life will be evaluated through the Psychosocial Impact Questionnaire of the Dental Internship validated for Brazil at the Federal University of São Paulo (UNIFESP) 3 months after the end of the bleaching.

  5. Histomorphometric evaluation [ Time Frame: baseline ]
    will be histomorphometric analyzed to measure possible inflammatory gum changes by the Violet LED light (405 nm) irradiation.



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • negative medical history,
  • Good systemic and oral health
  • Patients with aesthetic complaint of discoloration of upper and lower teeth
  • Patients with aesthetic desire for gingivoplasty, regardless of color in the baseline (Group 4), without the need for a prosthetic procedure and with sufficient gingiva inserted
  • Color in the baseline higher than the A2 of the vita scale for groups 1, 2 and 3.

Exclusion Criteria:

  • Patients with dentin hypersensitivity, incisal and occlusal wear or open cavities;
  • Patients with pulp alterations;
  • Carriers of dental anomalies;
  • Patients with dental fractures who do not have restorations on the buccal surface of the teeth to be cleared;
  • Patients who have had dental bleaching for less than 2 years;
  • Holders of fixed appliances, orthopedic;
  • Teeth pigmented by intrinsic factors;
  • Smokers;
  • Pregnant and Infants;
  • Patients reporting adverse reactions to Hydrogen Peroxide;
  • Patients who are taking ferrous sulfate medication;
  • Patients who use chronic decorticosteroids, as well as volunteers who are taking analgesics or anti-inflammatories.
  • Individual or removable prosthesis holders on the analyzed teeth will also be excluded or patients with endodontically treated teeth (Teeth 15-25 and 45-35).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03192852


Contacts
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Contact: Anna CR Horliana, PhD +55 01133859241 annacrth@gmail.com
Contact: Ana EC Santos, MS +55 01133859241 anaelizagarrini@gmail.com

Locations
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Brazil
University of Nove de Julho (UNINOVE)
São Paulo, Brazil, 01504-001
Sponsors and Collaborators
University of Nove de Julho
Investigators
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Study Chair: Ana EC Santos, MS University of Nove de Julho

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Anna Carolina Ratto Tempestini Horliana, Professor of postgraduate program in Biophotonics Applied to Health Sciences, University of Nove de Julho, UNINOVE, São Paulo, Brazil, University of Nove de Julho
ClinicalTrials.gov Identifier: NCT03192852     History of Changes
Other Study ID Numbers: 2.034.518
First Posted: June 20, 2017    Key Record Dates
Last Update Posted: June 23, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: After completing the data search, it is published in indexed journals with high impact factor

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Anna Carolina Ratto Tempestini Horliana, University of Nove de Julho:
Tooth bleaching color
dental esthetic
Clinical Trial
Violet LED light
Violet LED
color
sensibility
dental aesthetic